NCT01846845

Evaluation of a Novel Transfemoral Prosthetic Socket System

Prosthetic Socket System: Pilot Assessment

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Ohio Willow Wood · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a novel prosthetic transfemoral socket system. A conventional prosthesis will be compared to the novel transfemoral socket system.

Detailed description

Conventional transfemoral socket designs impose an array of limitations on transfemoral amputee patients. Flexion, extension, and abduction are considerably impaired and end basic functions like sitting are usually uncomfortable or even painful. An alternative socket design that lowers the socket trim-lines and still provides structural support would greatly improve the socket comfort for transfemoral amputees.

Conditions

• Lower Limb Amputation

Interventions

Type	Name	Description
DEVICE	Conventional Prosthetic Transfemoral Socket System	Conventional transfemoral may include an ischial containment socket, a pin suspension socket, and/or suction suspension socket
DEVICE	Novel Prosthetic transfemoral socket system	Prosthetic socket that incorporates lower socket trim-lines and transfemoral vacuum suspension

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-05-03
• Last updated: 2013-07-01

Locations

2 sites across 1 country: United States